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Sdtm Jobs (NOW HIRING)

SystImmune, Inc

Statistical Programmer

Redmond, WA · On-site

$80K - $100K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Create and/or review SDTM/ADaM mapping specifications and annotated CRFs (aCRFs). * Generate and/or validate SDTM and ADaM datasets, including associated Define.xml and reviewer's guides. * Develop ...

Systimmune

Statistical Programmer

Redmond, WA · On-site

$80K - $100K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Create and/or review SDTM/ADaM mapping specifications and annotated CRFs (aCRFs). * Generate and/or validate SDTM and ADaM datasets, including associated Define.xml and reviewer's guides. * Develop ...

VENESCO, LLC

SAS Programmer

Fort Detrick, MD · On-site

$135K - $148K/yr

Generate SDTM, ADaM, and SEND datasets. * Develop define.xml files and reviewer guides. * Create programming validation plans and reports. * Develop randomization programs and statistical outputs.

Fortrea

Senior Programmer Analyst- Remote, US

$80K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Develop/validate Custom/Complex SAS / SDTM datasets and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database or enhancements to the SAS ...

Fortrea

Senior Programmer Analyst- Remote, US

$80K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Develop/validate Custom/Complex SAS / SDTM datasets and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database or enhancements to the SAS ...

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How much do sdtm jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for sdtm in the United States is $54.04, according to ZipRecruiter salary data. Most workers in this role earn between $41.59 and $68.03 per hour, depending on experience, location, and employer.

What is an SDTM?

An SDTM job involves working with the Study Data Tabulation Model (SDTM), a standardized format required by regulatory agencies like the FDA for clinical trial data submission. Professionals in this role convert raw clinical data into SDTM-compliant datasets, ensuring consistency, traceability, and adherence to regulatory guidelines. Responsibilities often include data mapping, validation, and quality control to facilitate efficient review by regulatory bodies.

What does an SDTM programmer do?

As an SDTM Programmer, your daily tasks often include mapping raw clinical data into SDTM domains, validating datasets for compliance with CDISC standards, and generating documentation and specifications for regulatory submissions. You’ll frequently work with clinical data managers, statisticians, and other programmers to ensure data integrity and resolve any data-related queries that arise. Collaboration and timely troubleshooting are key, as your work supports the efficient progression of clinical studies through regulatory review. The role tends to be dynamic and deadline-driven, making organizational skills and adaptability important for success.

What are the key skills and qualifications needed to thrive as an SDTM programmer?

To thrive as an SDTM (Study Data Tabulation Model) Programmer, you need a strong background in clinical data standards, SAS programming, and an understanding of FDA submission requirements, usually supported by a degree in a scientific, mathematical, or computer-related field. Expertise with CDISC standards, SDTM IGs (Implementation Guides), and tools such as Pinnacle 21 Validator or JReview is essential. Strong analytical skills, attention to detail, effective communication, and the ability to collaborate across multidisciplinary teams are vital soft skills. These competencies are crucial for ensuring high-quality, regulatory-compliant clinical trial data that supports successful drug approval processes.

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Sdtm jobs near you
Infographic showing various Sdtm job openings in the United States as of August 2026, with employment types broken down into 52% Full Time, 46% Part Time, and 2% Contract. Highlights an 45% Physical, 2% Hybrid, and 53% Remote job distribution, with an average salary of $112,399 per year, or $54 per hour.

Senior Manager, Statistical Programming (Remote)

Penfield Search Partners

Fairfield, CT • On-site, Remote

Full-time

Posted 18 hours ago

Posted today

Job description

Contact: Lauren Scutero -
No 3rd party candidates
The Senior Manager of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks.

This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this position will play an important role in establishing SOPs and programming standards, and modernizing statistical reporting with open-source tools.


Essential Duties and Responsibilities
Key Project Responsibilities:

  • Provide programming leadership and oversee study to compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams.
  • Serve as the lead programmer to review the SAP, Data Presentation Plan, and Table Shells to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
  • Lead programming team to produce and/or validate SDTM, ADaM, and TLF for CSR and regulatory requests, publication needs, and ad-hoc analyses.
  • Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
  • Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.
  • Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
  • Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team.
  • Develop robust programs to create define.xml. Lead the NDA eSubmission package preparation.

Initiative Responsibilities:

  • Under the guidance of the Head of Statistical Programming and Compound Lead, implement innovative strategies and technologies to enhance programming processes.
  • Working with the manager, establish Statistical Programming standards and deploy programming strategies, specifications, and programmed analyses.
  • Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability.


Qualifications and Preferred Skills
Education:

  • Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.

Experience and Skill Set:

  • Minimum of 6 years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment.
  • Advanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming.
  • Python programming experience is desirable.
  • Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
  • Good knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology.
  • Broad expertise in statistical programming and in developing computing strategies.
  • In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials.
  • Knowledge of data validation, define.xml generation using Pinnacle 21.
  • Results-oriented, with proven problem-solving skills and a strong interest in continued learning.
  • Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams.
  • Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors.
  • Adaptable and able to thrive in a fast-paced, startup environment while managing multiple priorities effectively.
  • Experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.